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Functional Capacity and Quality of Life in Patients With Vascular Ring

Functional Capacity and Quality of Life in Patients With Vascular Ring

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04781738
Enrollment
30
Registered
2021-03-04
Start date
2018-03-15
Completion date
2022-02-28
Last updated
2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Ring

Keywords

Cardiopulmonary exercise testing,, Double aortic arch

Brief summary

To investigate the long term functional capacity and quality of life of patients with a history of vascular ring whether they did or did not have corrective surgery. Patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire.

Detailed description

Vascular rings are congenital vascular anomalies of the aortic arch that compress the esophagus and the trachea. The most common vascular rings are double aortic arch and right aortic arch with left ligamentum. Pulmonary artery sling is less common. Another cause of tracheal compression occurring only in infants is the innominate artery compression syndrome. When patients are symptomatic, surgical correction should be performed. data regarding long term functional capacity and quality of life is lacking. our aim is to investigate the long term functional capacity and quality of life of patients with history of vascular ring whether they did or did not have corrective surgery. Methods: a prospective study evaluating functional capacity and quality of life the patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire (sf-36).

Interventions

DIAGNOSTIC_TESTCardiopulmonary exercise test

CPET using a cycle ergometer (COSMED, Rome, Italy) beginning with no resistance warmup lasting 1-3 minutes followed with an incrementing resistance adapted to the patient's functional capacities according to the examiner's free judgment by successive stages Six minute walk test - patients will be instructed to walk as far as possible for six minutes in a 30-meter long enclosed corridor with a flat and hard surface, marked at every meter. Meters will be calculated at the end of the test. SF-36 is a questionnaire that contains eight domains - physical functioning (10 items); role limitations due to physical functioning (4 items); role limitations due to emotional problems (3 items); energy and vitality (4 items); mental health (5 items); social functioning (2 items); bodily pain (2 items); and general health perceptions (5 items). Scores are summed for each domain and were transformed into scores of between 0 (worst possible health state) to 100 (best possible health state).

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with history of vascular ring

Exclusion criteria

* refusal to participate * inability to complete cardiopulmonary testing

Design outcomes

Primary

MeasureTime frameDescription
Exercise capacityMeasured continuously during 15 minutes of the exercise test (CPET)Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)

Secondary

MeasureTime frameDescription
Six minute walk testSix minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)The distance gained after six minute of habitual walking.
Quality of life - SF-36Five minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)The calculated result of SF-36 questionnaire

Countries

Israel

Contacts

Primary ContactLea Bentur, MD
l_bentur@rambam.health.gov.il+972-4-7774360
Backup ContactVered Nir, MD
v_nir@rambam.health.gov.il+972-4-7774360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026